Robot-assisted verticalisation for patients with severe disorders of consciousness

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00035283

Enrollment

Registered

2024-10-15

Start date

2024-11-04

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired brain damage due to stroke (ICB/ischaemic), TBI or hypoxic-ischaemic encephalopathy

Interventions

Group 1: Four-week mobilisation of patients using a verticalisation robot at the patients bedside Group 2: Four-week mobilisation of patients through manual verticalisation by therapists

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Acquired brain damage due to stroke (ICB/ischaemic), TBI or hypoxic-ischaemic encephalopathy - Between 28 days and 6 months after injury - Syndrome of unresponsive wakefulness (SRW) or syndrome of minimal consciousness (SMB), diagnosed by two CRS-R measurements - Height 150-195cm

Exclusion criteria

Exclusion criteria: - Pre-existing disturbance of consciousness - Sepsis - Spasticity of the lower extremity with a Modified Ashworth Score (MAS) > 2 points - Hypoxia with clear SRW eight weeks after injury - Sedation (either continuous i.v. or intermittent in the form of benzodiazepines) - Body weight > 180kg - Foreseeable discharge or transfer within less than 8 weeks

Design outcomes

Primary

Measure	Time frame
Recovery of consciousness, measured with the Coma Recovery Scale-Revised (Giacino et al., 2004) and the Glasgow Outcome Scale-Extended (McMillan et al., 2016) and an associated decrease in disability as measured by the Disability Rating Scale (Bellon et al., 2012)	—

Secondary

Measure	Time frame
Physical load of the users of the therapy, measured with the NASA Task-Load index (Hart, 2006), verticalisation time per day, measured with the Aktigraph, severity of spasticity in the lower extremity, measured with the Modified Ashworth Scale (Schädler e tal., 2006), patients' daily living skills measured with the Barthel Index, functional independence measured with the Functional Independence Measure, duration of weaning from ventilation and/or tracheal cannula, functional connectivity of the neuronal network measured with high-resolution electroencephalography.	—

Measure

Time frame

Physical load of the users of the therapy, measured with the NASA Task-Load index (Hart, 2006), verticalisation time per day, measured with the Aktigraph, severity of spasticity in the lower extremity, measured with the Modified Ashworth Scale (Schädler e tal., 2006), patients' daily living skills measured with the Barthel Index, functional independence measured with the Functional Independence Measure, duration of weaning from ventilation and/or tracheal cannula, functional connectivity of the neuronal network measured with high-resolution electroencephalography.

—

Countries

Germany

Contacts

Public ContactMartin Rosenfelder

Therapiezentrum Burgau

m.rosenfelder@therapiezentrum-burgau.de+49 8222 404138

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026